Group 1 - The company Boji Pharmaceutical (300404.SZ) has received approval from the National Medical Products Administration for the clinical trial of its drug "FCZR" [1] - FCZR is a modified new drug of category 2.2/2.4, optimized based on known active ingredients, with significant clinical advantages, targeting the indication of ear fungal disease [1] - Ear fungal disease is a common infectious condition in otolaryngology, often recurring and difficult to cure, particularly prevalent in hot and humid seasons and regions [1] Group 2 - The formulation of FCZR offers advantages in fluidity and ease of administration, allowing for direct contact with lesions in the ear canal through ear drops, thus achieving localized therapeutic effects [1] - Currently, there are no similar drugs approved for sale in both domestic and international markets, and there are no related sales data available [1]

Core Viewpoint - Boji Pharmaceutical has received approval from the National Medical Products Administration for its clinical trial of the new drug "FCZR," which targets ear fungal infections and offers significant clinical advantages over existing treatments [1] Company Summary - Boji Pharmaceutical (300404.SZ) has announced the approval of its drug "FCZR" for clinical trials, indicating progress in its product development pipeline [1] - The drug is classified as a modified new drug of category 2.2/2.4, optimized for formulation, prescription process, administration route, and indications [1] Industry Summary - Ear fungal disease is a common infectious condition in otolaryngology, particularly prevalent in hot and humid seasons and regions, often recurring and difficult to cure [1] - Currently, there are no approved drugs for this condition in both domestic and international markets, highlighting a potential market opportunity for FCZR [1]

Core Viewpoint - The company has received approval from the National Medical Products Administration for its drug "FCZR," which is intended for the treatment of ear fungal disease, marking a significant milestone in its new drug development process [1] Group 1: Drug Approval - The drug "FCZR" has been granted a clinical trial approval notice with the registration classification of chemical drug categories 2.2/2.4 [1] - The approval notice numbers are 2025LP02257 and 2025LP02258, indicating the official sanction to commence clinical trials [1] - This type of drug formulation offers advantages in terms of fluidity and ease of administration [1] Group 2: Market Context - Currently, there are no similar drugs approved for market use domestically or internationally, highlighting the uniqueness of "FCZR" [1] - The approval represents a phase of achievement in the company's new drug research and development efforts [1] - The impact of this approval on the company's overall business performance is expected to be minor [1]

Core Viewpoint - The company Boji Pharmaceutical has received approval from the National Medical Products Administration for its clinical trial of the new drug "FCZR," which targets ear fungal infections and offers significant clinical advantages [1] Company Summary - Boji Pharmaceutical (300404.SZ) announced the approval of its clinical trial for "FCZR" [1] - FCZR is classified as a modified new drug of category 2.2/2.4, optimized in formulation, prescription process, administration route, and indications [1] - The intended indication for FCZR is ear fungal disease, a common infectious condition in otolaryngology, particularly prevalent in hot and humid seasons and regions [1] Industry Summary - Ear fungal disease is a frequently occurring infection that is often recurrent and difficult to cure [1] - The formulation of FCZR offers advantages in fluidity and ease of administration, allowing for direct contact with lesions in the ear canal through ear drops, thus enabling localized treatment [1] - Currently, there are no similar drugs approved for sale in both domestic and international markets, and there are no related sales data available [1]

一、 药物基本情况 1、通知书编号：2025LP02257、2025LP02258（同药品不同规格） 2、药品名称：FCZR 证券代码：300404 证券简称：博济医药 公告编号：2025-071 博济医药科技股份有限公司 关于公司获得药物临床试验批准通知书的公告 本公司及董事会全体成员保证信息披露的内容真实、准确、完整，没有虚假 记载、误导性陈述或重大遗漏。 近日，博济医药科技股份有限公司（以下简称"公司"）申报的"FCZR" 获得国家药品监督管理局核准签发的《药物临床试验批准通知书》。现将相关情 况公告如下： 根据我国药品注册相关法律法规要求，药品在取得药物临床批准后，须按照 批件内容进行研究工作并经国家药品监督管理局审批通过后方可上市。 1 3、适应症：耳真菌病 4、注册分类：化学药品 2.2/2.4 类 5、审批结论：根据《中华人民共和国药品管理法》及有关规定，经审查， 2025 年 6 月 19 日受理的 FCZR 临床试验申请符合药品注册的有关要求，同意开 展临床试验。 二、 药物其他情况 FCZR 是在已知活性成份的基础上，对其剂型、处方工艺、给药途径、适应 症等进行优化，且具有明显临床优势的 ...

Financial Performance - The company's total revenue for the first half of 2025 was 361 million yuan, an increase of 5.88% year-on-year [1] - The net profit attributable to shareholders was 15.57 million yuan, a decrease of 48.33% year-on-year [1] - The gross profit margin was 30.65%, down 6.03% year-on-year, while the net profit margin was 4.86%, down 46.3% year-on-year [1] - The company reported a significant increase in operating cash flow per share, which rose by 342.15% to 0.06 yuan [1] Business Operations - Clinical research service revenue reached approximately 290 million yuan, a year-on-year increase of 6.78% [4] - The company signed new clinical research service contracts worth 752 million yuan, showing growth compared to the previous year [4] - The company is expanding its clinical business team and has seen a noticeable increase in the number of clinical projects it is bidding for [4] Market Position and Competition - The company is positioned as a leading CRO with strong履约能力 and rich experience, benefiting from the difficulties faced by smaller CROs in the market [5] - The industry is expected to see increased concentration as smaller CROs struggle with operations, layoffs, and even closures [5] Research and Development - The company has several ongoing self-developed projects, including traditional Chinese medicine and chemical drugs, with notable projects in various stages of development [6] - The company is actively seeking partners for its self-developed projects and aims to enhance its innovation capabilities [12] Future Outlook - The company aims to achieve a revenue target for 2025 based on the 2024 stock incentive plan and plans to control expenses while expanding business orders [9] - The company anticipates an increase in gross margins for its clinical CRO business due to rising prices driven by improved funding for innovative drug development [10] - The company has a significant amount of unrecognized revenue from signed contracts, estimated at approximately 3.195 billion yuan, with expected revenue recognition of about 480 million yuan in the second half of 2025 [14]

Group 1: Clinical Research Organization (CRO) Business Development - In the first half of 2025, the company's clinical research service revenue was approximately CNY 290 million, representing a 6.78% decrease compared to the same period last year [2] - The new clinical research service contract amount was CNY 752 million, indicating growth in market demand for clinical CRO services [2] - The company is expanding its clinical business team and expects clinical business prices to rise due to improved financing conditions [2] Group 2: Market Competition and Industry Trends - Many small CRO companies are facing operational difficulties, leading to layoffs and even closures, which is expected to increase industry concentration [3] - The company, being a well-established CRO, has strong performance capabilities and competitive advantages [3] Group 3: Research and Development Progress - The company has several self-developed projects, including a Class 1 innovative drug for chronic heart failure and various traditional Chinese medicine projects [4] - In the first half of 2025, new signed orders amounted to CNY 870 million, with over 50% from chemical drugs and over 20% from traditional Chinese medicine [4] Group 4: Future Business Plans and Financial Projections - The company plans to increase clinical staff in the second half of 2025, but not on a large scale [5] - The company aims to achieve revenue targets based on the 2024 stock incentive plan and expects to confirm approximately CNY 480 million in revenue in the second half of 2025 [7][11] - The gross margin for clinical CRO services is expected to increase due to higher quality demands and improved funding for innovative drug development [8] Group 5: Collaboration and Mergers - The company is open to mergers and acquisitions, particularly in the fields of vaccines and blood products, while focusing on its core business [12] - The company is actively seeking partners for its self-developed projects, including the "Runnor9591" project [6] Group 6: Regulatory and Operational Efficiency - The execution cycle for clinical projects varies, with significant improvements in efficiency and quality compared to previous years [10] - The company anticipates a decrease in expense ratios as revenue grows, with stable personnel levels [11]

Investment Rating - The report maintains a "Buy" rating for the company, indicating a positive outlook for future performance [6]. Core Insights - The company's clinical business shows stable growth, with a revenue of 290 million yuan in H1 2025, reflecting a year-over-year increase of 6.78%. However, the gross margin for this segment has slightly declined [2]. - The non-clinical business performance is mixed, with preclinical research services experiencing a revenue decrease of 2.21% year-over-year, while other consulting services saw a significant increase of 31.79% [3]. - The company has made progress in its self-developed projects, including innovative traditional Chinese medicine and chemical drug candidates, which could enhance profitability if successfully licensed [3]. - The operating cash flow has significantly improved, reaching 21.25 million yuan in H1 2025, a substantial increase of 343.46% compared to the previous year [4]. Summary by Sections Financial Performance - The company reported a total revenue of 361 million yuan for H1 2025, a year-over-year increase of 5.88%. However, the net profit attributable to shareholders decreased by 48.33% to 15.57 million yuan [1]. - The gross margin for clinical services was 30.6%, showing a slight decline of 0.6 percentage points year-over-year [2]. Business Segments - Clinical research services generated 290 million yuan in revenue, with a new contract amount of 752 million yuan, indicating slight growth from the previous year [2]. - Preclinical research services generated 40.87 million yuan, while other consulting services brought in 23.49 million yuan, marking a significant increase [3]. Cash Flow and Operational Efficiency - The net cash flow from operating activities reached 21.25 million yuan, a notable increase from 4.79 million yuan in the same period last year, reflecting improved cash collection efficiency [4]. Profit Forecast and Valuation - The profit forecast for 2025-2026 has been revised downwards, with net profit estimates of 45 million yuan and 66 million yuan respectively. The current stock price corresponds to a P/E ratio of 98 for 2025 [4].

Company Performance - Boji Pharmaceutical (SZ 300404) reported a revenue of approximately 361 million yuan for the first half of 2025, representing a year-on-year increase of 5.88% [1] - The net profit attributable to shareholders was approximately 15.57 million yuan, showing a year-on-year decrease of 48.33% [1] - Basic earnings per share were 0.0407 yuan, which is a year-on-year decrease of 48.42% [1] Industry Insights - The pet industry is experiencing significant growth, with a market size of 300 billion yuan, leading to a surge in stock prices for related companies [1]

Core Viewpoint - The legal opinion issued by Beijing Kangda Law Firm confirms the validity and compliance of the stock incentive plan of Boji Pharmaceutical Technology Co., Ltd, particularly regarding the cancellation of certain restricted stocks [1][12]. Group 1: Legal Compliance and Verification - The law firm conducted thorough verification and confirmed that all provided documents and statements from Boji Pharmaceutical were authentic and accurate [2][3]. - The legal opinion is strictly focused on legal issues related to the incentive plan and does not cover accounting, financial, or auditing matters [2][3]. Group 2: Stock Incentive Plan Details - The company approved the 2023 restricted stock incentive plan, granting a total of 2,968,000 shares to 47 eligible participants, with the first grant date set for April 26, 2023 [3][4]. - The first category of restricted stocks was granted at a price of 5.47 CNY per share, while the second category was granted at 8.75 CNY per share [3][4]. - Adjustments were made to the grant prices following the annual profit distribution, reducing the first category price to 5.46 CNY and the second category price to 8.74 CNY [4][7]. Group 3: Cancellation of Restricted Stocks - The company decided to cancel 140,600 shares of the second category of restricted stocks due to certain participants failing to meet performance criteria or leaving the company [5][10]. - An additional 300,000 shares from the reserved portion of the second category were also rendered invalid due to not being granted within the stipulated timeframe [5][10]. - The legal opinion asserts that the cancellation of these stocks has received the necessary approvals and complies with relevant regulations [11][12].